NCT04746820 Functional Near-infrared Spectroscopy in Unconscious Patients
| NCT ID | NCT04746820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emanuela Keller |
| Condition | Nervous System Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-01-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-01-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: * The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. * If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.
Eligibility Criteria
Inclusion Criteria - experimental group: * Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation treated at the Institute of Intensive Care Medicine, University Hospital Zurich * Unconsciousness (GCS \< 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious patients are defined as not responding to verbal stimuli. The motor response to pain should be one of the following: no response to pain / extensor response / flexor response / localize to pain) * Age ≥ 18 years * Signed informed consent obtained from legal representative * Measurement logistically and technical possible within the first 7 days after admission Inclusion Criteria - control group: * Subjects of either sex * Conscious (GCS = 15) * Age ≥ 18 years * Signed informed consent Exclusion Criteria - experimental group: * Patients age \< 18 years * Positive pregnancy test for any female of childbearing potential or breast feeding female * Previous auditory complaints or any ear diseases * No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.) * Any history of previous cerebral or brainstem disease * Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability) * Acute status epilepticus * Clinical recovery (GCS ≥ 9) or death before enrolment of the study Exclusion Criteria - control group: * Subjects age \< 18 years * Positive pregnancy test for any female of childbearing potential or breast feeding female * Previous auditory complaints or any ear diseases * No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.) * Any history of previous cerebral or brainstem disease
Contact & Investigator
Emanuela Keller, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital, Zürich
Frequently Asked Questions
Who can join the NCT04746820 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nervous System Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04746820 currently recruiting?
Yes, NCT04746820 is actively recruiting participants. Contact the research team at emanuela.keller@usz.ch for enrollment information.
Where is the NCT04746820 trial being conducted?
This trial is being conducted at Zurich, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT04746820 clinical trial?
NCT04746820 is sponsored by Emanuela Keller. The principal investigator is Emanuela Keller, Prof. Dr. at University Hospital, Zürich. The trial plans to enroll 30 participants.